The purpose of this first in human study is to evaluate the safety of treatment with autologous T cells genetically modified to express a CER (chimeric endocrine receptor) targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.
Aged 18 years or older and able to provide informed consent.
Pathologically confirmed diagnosis of invasive (Grades 1-3) epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma (EOC), which are serous, endometrioid, clear cell, mucinous, mixed epithelial, or undifferentiated. Borderline serous ovarian tumors (BOT, also known as serous low-malignant potential tumors) are included, as are mixed invasive/borderline cancers. Patients may also have sex cord-stromal tumors (SCSTs) to include adult-type granulosa cell tumors (GCTs) and Sertoli Leydig cell tumors (SLCTs), or SCSTs with mixed elements that include at least one of these types.
Have measurable disease or detectable (non-measurable) disease.
Consent to have tumor obtained for correlative study testing.
Known active hepatitis B infection, known history of hepatitis C or HIV infection.
Clinical or radiographic evidence of bowel obstruction or need for parenteral hydration and/or nutrition.
Known or suspected extensive abdominal adhesions that would preclude port placement or infusion.
Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen). Such conditions include but are not limited to systemic lupus erythematous, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis.
Parallel
Follicle Stimulating Hormone Receptor T Cells
DrugParticipants will receive an infusion of autologous t cells genetically modified ex vivo to express the FSHR-specific 4-1BB/CD3ζ CER.
10
Treatment groupsSee each treatment group below.
Maximum Tolerated Dose of FSHCER T Cells
Participants will receive escalating doses of FSHCER T Cells to determine the Maximum Tolerated Dose (MTD). MTD is defined as the the highest dose of t cells that does not cause unacceptable side effects.
Duration of Response
The duration of response is measured from the time measurement criteria are met for immune complete response or immune partial response (whichever is first recorded) until the first date that progressive disease (immune related progressive disease -irPD) is objectively documented (taking as reference for PD the smallest measurements recorded \[nadir\] since the treatment started).
Duration of Stable Disease
Stable Disease is measured from the start of the treatment until the criteria for confirmed progressive disease are met.
Overall Survival
Overall survival defined as the time from initial date of treatment to date of death.
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Anixa Biosciences, Inc.
Collaborator
